NCT05727111 Implementation of a HABIT-ILE Intervention at Home for Chronic Stroke
| NCT ID | NCT05727111 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université Catholique de Louvain |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2023-05-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will use a randomized controlled trial design to assess the possible difference between two intensive treatment programs: a classic "Hand and Arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) therapy and a HABIT-ILE therapy implemented at the patient's home. Moreover, this study also aims to assess whether the patient's abilities are better with follow-up than without follow-up after two weeks of HABIT-ILE therapy. The possible difference between the therapies will be studied in terms of functional capacities, activities and social participation.
Eligibility Criteria
Inclusion Criteria: * Adults with a chronic stroke (older than 6 months) * Ability to interact and understand simple instructions in order to complete assessments and therapy * Ability to perform a partial shoulder flexion or abduction, a partial elbow extension, and hold an object in the paretic hand * Availability of a caregiver for 6h30 per day during two weeks of therapy Exclusion Criteria: * Non controlled seizure * Botulinum toxin injection in the last 6 months before the first assessment or during the therapy * Intensive therapy in the last 6 months before the first assessment or during the therapy * Surgery that could affect the assessments or therapy in the last 6 months before the first assessment or during the therapy * Severe visual or cognitive impairments interfering with treatment and or assessments
Contact & Investigator
Yannick Bleyenheuft, Phd, Prof.
PRINCIPAL INVESTIGATOR
Université Catholique de Louvain
Frequently Asked Questions
Who can join the NCT05727111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05727111 currently recruiting?
Yes, NCT05727111 is actively recruiting participants. Contact the research team at yannick.bleyenheuft@uclouvain.be for enrollment information.
Where is the NCT05727111 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT05727111 clinical trial?
NCT05727111 is sponsored by Université Catholique de Louvain. The principal investigator is Yannick Bleyenheuft, Phd, Prof. at Université Catholique de Louvain. The trial plans to enroll 48 participants.
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